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Diss Factsheets

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Remarks:
other: Code of Federal Regulations, Title 16, Section 1500.42
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: scientifically acceptable and well documented

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report date:
1980

Materials and methods

Principles of method if other than guideline:
100 µl m-tolylisocyanate was applied into the conjunctival sac of the right eye of 6 rabbits. Reading was carried out 24, 48 and 72 h after start of application of the test substance.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
m-tolyl isocyanate
EC Number:
210-676-0
EC Name:
m-tolyl isocyanate
Cas Number:
621-29-4
Molecular formula:
C8H7NO
IUPAC Name:
1-isocyanato-3-methylbenzene

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Duration of treatment / exposure:
8 days (eye was not washed after application of the test substance)
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
6 animals

Results and discussion

In vivo

Results
Irritation parameter:
other: primary irritation index
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
54.1
Max. score:
110
Reversibility:
not fully reversible within: 8 d
Remarks on result:
positive indication of irritation
Irritant / corrosive response data:
Eight days after application of the test substance, a slow repair of the cornea damage was observed. The condition of the chemosis and the inflamation of the conjunctiva were unchanged, no repair was visible.

Any other information on results incl. tables

 








































































































































Irritation



                 24h



                48h



               72h



I.Cornea:


A-Opacity


B-Area


 


Max (80)



1



2



3



4



5



6



1



2



3



4



5



6



1



2



3



4



5



6



2



1



1



1



1



2



1



2



1



2



1



2



1



2



1



3



2



2



4


 


40



4


 


20



4


 


20



4


 


20



4


 


20



4


 


40



4


 


20



4


 


40



4


 


20



4


 


60



4


 


40



4


 


40



4


 


20



4


 


40



4


 


20



4


 


60


 



4


 


40


 



4


 


40



II.Iris:


Max (10)



0


0



1


5



0


0



0


0



0


0



0


0



0


0



1


5



2


10



1


5



1


5



1


5



1


5



2


10



1


5



1


5



1


5



1


5



III.Conjunctive:


A-Redness


B-Chemosis


C-Discharge


 


Max (20)



 


2


4


2


 


16



 


2


4


3


 


18



 


2


4


2


 


16



 


2


4


2


 


16



 


2


4


3


 


18



 


2


4


3


 


18



 


2


4


3


 


18



 


2


4


3


 


20



 


3


4


3


 


20



 


3


4


3


 


20



 


3


4


3


 


20



 


3


4


3


 


20



 


3


4


3


 


18



 


2


4


3


 


20



 


3


4


3


 


20



 


3


4


3


 


20



 


3


4


3


 


20



 


3


4


3


 


20



Max (110)



56



43



36



36



38



58



43



70



45



65



45



65



43



70



45



85



65



65



 


 






























































Irritation



                After 8 days



I.Cornea:


A-Opacity


B-Area


Max (80)



1



2



3



4



5



6



2



2



1



3



2



2



4


 



3



3



3



2



4



II.Iris:


Max (10)



2


 



2


 



1


 



1


 



1


 



1


 



III.Conjunctive:


A-Redness


B-Chemosis


C-Discharge


Max (20)



 


3


4


3



 


3


4


3



 


3


4


3



 


3


4


2



 


3


4


3



 


3


4


3



Max (110)



 



 



 



 



 



 



 


The total sum is divided by 18 and gives the degree of primary irritation on the eye.


 

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
In accordance with the provisions of Directive 67/548/EEC amended by COMMISSION DIRECTIVE 2001/59/EC of 6 August 2001, Annex VI, classified as GHS category 1.
Executive summary:

100 µl m-tolylisocyanate was applied into the conjunctival sac of the right eye of 6 rabbits. Reading was carried out 24, 48 and 72 h after start of application of the test substance.

Eight days after application of the test substance, a slow repair of the corneal damage was observed. The condition of the chemosis and the inflamation of the conjunctiva were unchanged, no repair was visible.

A primary irritation index of 54.1 was found. The test-substance m-tolylisocyanate is highly irritating (R 41) to the eyes.